LUPIN LTD FDA Approval ANDA 203003

ANDA 203003

LUPIN LTD

FDA Drug Application

Application #203003

Application Sponsors

ANDA 203003LUPIN LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL12.5MG0MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE
002TABLET;ORAL25MG0MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE
003TABLET;ORAL50MG0MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-11

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA
002PrescriptionAA
003PrescriptionAA

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203003
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-11
        )

)

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